Validation Study of a Planned Approach to Manage Heart Conduction Issues After Transcatheter Aortic Valve Replacement

What this Trial Is About

Researchers are investigating conduction disturbances that occur after transcatheter aortic valve replacement TAVR, which pose significant challenges for patient care. This study aims to validate a pre-planned treatment strategy designed to manage these heart rhythm issues more consistently across many patients. The goal is to reduce the need for permanent pacemakers after TAVR while minimizing risks like sudden death or serious arrhythmias and avoiding extended hospital stays. The study follows a detailed algorithm for managing conduction disturbances based on patient ECG results immediately after TAVR and during the following days. Patients are grouped by their risk and ECG changes, with different monitoring and pacing recommendations for each group. This includes temporary pacing wires, continuous ECG monitoring, and possible electrophysiological studies to decide on permanent pacemaker implantation when needed. Participants undergo continuous ECG monitoring during their hospital stay and may continue monitoring after discharge. Researchers track the rate of successful use of the treatment strategy, frequency and timing of pacemaker implantations, and the occurrence of sudden death up to one year after TAVR. The study includes assessments like daily ECGs, telemetry, and long-term follow-up to evaluate the safety and effectiveness of the management plan for conduction disturbances post-TAVR.

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR